IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041223
First received: July 8, 2002
Last updated: November 5, 2013
Last verified: September 2002

July 8, 2002
November 5, 2013
September 2002
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Complete list of historical versions of study NCT00041223 on ClinicalTrials.gov Archive Site
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IH636 Grape Seed Extract in Treating Hardening of Breast Tissue in Women Who Have Undergone Radiation Therapy for Early Breast Cancer
Double-Blind, Placebo-Controlled, Randomized Phase II Trial of IH636 Grape Seed Proanthocyanidin Extract (GSPE) in Patients With Adverse Effects of High Dose Breast Radiotherapy

RATIONALE: IH636 grape seed extract may lessen hardening of breast tissue caused by radiation therapy and may help patients live more comfortably.

PURPOSE: Randomized phase II trial to study the effectiveness of IH636 grape seed extract in treating hardening of breast tissue in women who have undergone radiation therapy for early breast cancer.

OBJECTIVES:

  • Determine the efficacy of IH636 grape seed proanthocyanidin extract for the treatment of radiation-induced fibrosis after high-dose radiotherapy in women with a history of early breast cancer.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to time since prior radiotherapy. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive oral IH636 grape seed proanthocyanidin extract three times daily for 6 months.
  • Arm II: Patients receive an oral placebo three times daily for 6 months. Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 72 patients (48 for arm I and 24 for arm II) will be accrued for this study.

Interventional
Phase 2
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
  • Breast Cancer
  • Radiation Fibrosis
Dietary Supplement: IH636 grape seed proanthocyanidin extract
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • History of early breast cancer

    • T1-T3, N0-N1, M0
  • No evidence of cancer recurrence
  • Palpable breast induration due to prior radiotherapy
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 2 years since prior radiotherapy

Surgery:

  • Not specified

Other:

  • At least 3 months since prior dietary supplementation containing IH636 grape seed proanthocyanidin extract over 50 mg per day
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00041223
CDR0000069454, RMNHS-GRAPE-1991, RMNHS-1991, EU-20209
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Royal Marsden NHS Foundation Trust
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Study Chair: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
National Cancer Institute (NCI)
September 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP